Quality Engineer Opportunity
About the Role
We are seeking a highly skilled Quality Engineer to join our team at a well-established medical device manufacturing company in the Midlands. This is a full-time, 12-month contract position.
Key Responsibilities
* Coordinate quality assurance resources for materials inspection and operations
* Provide operational QA support for products and processes
* Conduct detailed root cause analysis and define corrective and preventive actions for non-conforming reports (NCRs)
* Participate in continuous improvement activities to streamline processes
* Work with engineering teams to identify trends in failures, support root cause analysis, and implement corrective actions
* Conduct internal audits and lead key assessment and technical audit (KATA) investigations to identify root causes
* Develop inspection plans for incoming inspections, in-process inspections, and final QA inspections for products manufactured
* Detailed review and approval of risk management files and change orders associated with components and manufacturing processes
Requirements
* Bachelor's degree in Engineering or Science discipline with a minimum of four years' experience working within a regulated industry
* Excellent working knowledge of ISO 13485 and 21 CFR 820 and MDSAP programs, along with exposure to other regulations
* Working familiarity with IEC 60601 is a distinct advantage
* Experience in working within a CAPA program and other quality management systems, as well as leading and participating in multiple projects concurrently
* Experience in internal auditing to QSRs and ISO 13485 requirements
* Strong problem-solving skills and attention to detail and accuracy are essential
* Ability to work well under deadlines and pressure
Preferred Skills
* IEC 60601
* CAPA
* Quality Assurance